Patients are 'the ones at risk'

June 11, 2006

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Two U.S. senators are calling on the U.S. Food and Drug Administration to respond to thousands of overdose deaths being blamed on the prescription painkiller methadone.A Sunday Gazette-Mail investigation published last week found that methadone is helping to kill more people nationwide than any other prescription narcotic, and West Virginia?s methadone death rate is the nation?s highest.Senate Finance Chairman Chuck Grassley, R-Iowa, and Sen. Jay Rockefeller, D-W.Va., said the FDA should move quickly to warn doctors and the public about the danger of misusing methadone.The overdose deaths also reveal problems with the FDA itself and its ability to protect the public, Grassley said.

Grassley held hearings in 2004 questioning why the FDA didn?t respond more quickly to deaths blamed on another prescription painkiller, Vioxx, which has been pulled off the market.?What?s happening with methadone underscores how serious it is that the FDA make dramatic improvements to how it scrutinizes drugs after they?re on the market,? Grassley said.Rockefeller said, ?The serious problem of methadone overdose requires much greater scrutiny and the FDA needs to immediately improve its oversight efforts.?For far too long the FDA has been lax on drug safety, which is unacceptable for an agency whose mission is to protect consumers. If the FDA fails to act quickly, Congress must step in and force the FDA to do its job.?Methadone once was given mostly to heroin addicts to stop their cravings for the illegal drug. Recently, more doctors are prescribing it to treat pain. Insurance companies favor it because it is cheap and effective.Methadone helped to kill 2,992 people in 2003, up from 790 in 1999, according to an analysis of death certificates conducted by the National Center for Health Statistics at the request of the Gazette-Mail.The drug was blamed for more deaths than heroin and about 1,500 fewer deaths than all other narcotic painkillers combined, including oxycodone, fentanyl, morphine and hyrdocodone.Many methadone overdose victims stole the drug or took it improperly. But some victims took the drug as prescribed and died anyway, the Gazette-Mail found.
A Utah study found that 42 percent of methadone overdose victims had a valid prescription for the drug. In West Virginia, one in five victims had no other drug but methadone in their bodies, and others had small, usually harmless amounts of alcohol or acetaminophen.The package insert that comes with methadone contains dangerous and potentially deadly language about the ?usual adult dosage? of methadone, according to several physicians and pain researchers contacted by the Gazette-Mail. The drug manufacturer writes the language and the FDA approves it.?The usual adult dosage is 2.5 mg to 10 mg every three or four hours as necessary,? reads the drug?s package insert under ?For Relief of Pain.?

Someone reading that label could believe it is safe for an adult to consume up to 80 milligrams of methadone a day.But 50 milligrams of methadone or less can kill a patient not used to strong painkillers, studies say.?Most people would die if they took 80 milligrams a day,? said Lynn Webster, a pain doctor and researcher from Utah. ?That?s an extremely dangerous, liberal guideline.?An FDA spokeswoman said the agency was working with the makers of methadone to make appropriate changes to the labeling for methadone painkillers.

But one of the largest manufacturers of methadone said the FDA hasn?t talked to them.?Roxane Laboratories has not been contacted by the FDA regarding any possible labeling changes for methadone tablets,? said spokeswoman Dawn Plante.

Another large maker of methadone, Tyco/Mallinckrodt, when asked for details about what changes might be made, referred a reporter to the FDA.Patients are on their ownEven if the FDA decided to change the label on methadone tomorrow, the agency could not do it immediately. Congress has forced the FDA to collaborate with a drug?s manufacturer before a warning can be added to a package insert.Drug company lawyers can veto any proposed warnings, said Larry Sasich, a Pennsylvania pharmacist and consultant for the consumer group Public Citizen.?The agency has asked for more money and more authority,? Sasich said, ?but Congress has refused to give it to them.?Most of the FDA?s money and energy is spent on approving new drugs, Sasich said. But funding for surveillance ? making sure existing drugs are safe ? has remained flat for over a decade.The FDA has a system, called MedWatch, for tracking problems with prescription drugs, but health officials are not required to report to it, so it captures only a tiny percentage of overdoses, he said.Grassley and Sen. Christopher Dodd, D-Conn., have introduced a bill that would overhaul the FDA?s drug safety office and give it more independence and power within the agency. Rockefeller now plans to join as a co-sponsor of the bill, said spokeswoman Wendy Morigi.The bill has been bottled up for more than a year in the Senate Committee on Health, Education, Labor and Pensions, whose chairman is Sen. Michael Enzi, R-Wyoming.Grassley said the FDA could do more to warn the public, even without his bill.?But legislation takes a long time, and the FDA has a moral and institutional responsibility to take action on its own, as well, to respond to the kind of data that?s resulting from these tragic deaths,? he said.The FDA could send out a ?public health advisory? warning doctors of the increase in methadone deaths, like it did recently for the drug fentanyl, Sasich said.FDA spokeswoman Laura Alvey declined to say whether the FDA will issue a public health advisory about methadone.Sasich said that under the current system, patients are left to fend for themselves too often. They have to educate themselves, because they cannot trust the agencies that are supposed to protect them.?The patients have to know about it. They?re the ones at risk,? Sasich said. ?Pharmacists, physicians and federal bureaucrats don?t get adverse drug reactions. Patients do.?To read the rest of the series, The Killer Cure, go to www.wvgazette.com/section/Series/The Killer CureTo contact staff writers Scott Finn and Tara Tuckwiller, use e-mail or call 357-4323 or 348-5189.